Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Hepatitis B

Treatments: Drug: Adefovir (ADV); Drug: Entecavir (ETV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00065507

AI463-048

Details and patient eligibility

About

This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.

Enrollment: 195 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Child-Pugh (CP) score >= 7
• Hepatitis B virus (HBV) viremia

Exclusion

• Alanine aminotransferase (ALT) > 15 x upper limit of normal (ULN)
• Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV) coinfection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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195 participants in 2 patient groups

A1

Experimental group

Treatment:

Drug: Entecavir (ETV)

A2

Active Comparator group

Treatment:

Drug: Adefovir (ADV)